Prostate Cancer
Conditions
Keywords
recurrent prostate cancer
Brief summary
RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.
Detailed description
OBJECTIVES: Primary * Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride. * Evaluate the toxicity of dutasteride in these patients. Secondary * Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride. * Determine the survival of patients treated with dutasteride. * Determine the quality of life of patients treated with dutasteride. OUTLINE: Patients receive oral dutasteride once daily until disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months thereafter. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Interventions
Oral
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of prostate cancer * Asymptomatic progressive disease despite androgen-deprivation therapy * Progression must occur during androgen-deprivation therapy comprising orchiectomy or luteinizing hormone-releasing hormone (LHRH) analogue with or without antiandrogen AND after antiandrogen withdrawal * Concurrent LHRH monotherapy (i.e., LHRH analogs, such as leuprolide acetate or goserelin) required in patients who did not undergo prior bilateral orchiectomy to assure testicular androgen suppression * Recurrent disease, as indicated by at least 1 of the following: * Prostate-specific antigen (PSA) at baseline ≥ 2.0 ng/mL * Biopsy-confirmed local recurrence * Increase in size of measurable lesions on radiographic study * New lesion on a nuclear bone scan * Two successive increases in serum PSA measured at least 1 week apart PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Bilirubin ≤ 2.0 mg/dL * SGOT ≤ 4 times upper limit of normal * Creatinine ≤ 2.0 mg/dL * Fertile patients must use effective contraception during and for 3 months after completion of study therapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered * At least 28 days since prior flutamide OR at least 42 days since prior bicalutamide or nilutamide * Patients who have previously progressed despite antiandrogen withdrawal and who have started antiandrogens without reduction of serum PSA are eligible without requiring a 28- or 42-day washout interval after antiandrogen withdrawal * No other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or LHRH analogues only) or antiandrogens * Surgery, brachytherapy, external-beam radiotherapy, and cryotherapy are not considered systemic therapies * No other concurrent anticancer therapy * No concurrent use of any of the following: * Finasteride * Other investigational 5α-reductase inhibitors * Anabolic steroids * Alpha-receptor blockers (e.g., indoramin, tamsulosin hydrochloride, prazosin, terazosin, alfuzosin hydrochloride, and doxazosin) * Drugs with antiandrogenic properties (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, and progestational agents) * Products containing selenium ≥ 75 mcg or vitamin E ≥ 100 IU * Saw palmetto * EG6761 * No concurrent radiotherapy, including palliative radiotherapy for pain control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease progression | Every 12 weeks |
| Toxicity | Daily while on Treatment |
Secondary
| Measure | Time frame |
|---|---|
| Objective response (complete and partial) rate and serum prostate-specific antigen levels | Every 4 weeks |
| Survival | Every 12 weeks |
Countries
United States